Associate Scientist III

Job Description

Job Summary:

• Company Rare Disease is seeking an Associate Scientist III to join the client in Durham, NC.
• This role supports both upstream and downstream operations with a particular focus on sample coordination, harvest train activities, and data recording/analysis to enable reliable production of AAV vectors.
• Candidates with direct, hands-on AAV production experience will be prioritized.

Duties and Responsibilities:

Upstream support:

• Assist with cell expansion, transfection, and bioreactor (Ambr250 to 50L stir tank) operations, routine in-process sampling, and monitoring of process parameters.

Downstream support: 

• Participate in clarification, chromatography, and TFF/filtration steps; assemble/disassemble and clean harvest train components; and stage materials.

Sample management:

• Coordinate sample plans across unit operations; label samples accurately and per SOPs; maintain chain-of-custody and timely delivery to QC/analytics.

Equipment operations: 

• Perform setup, operation, and teardown of harvest trains, pumps, filters, tubing sets, single-use systems, and ancillary equipment; support/perform pre-use checks and readiness.

Data capture and analysis: 

• Accurately record process data, batch records, and logbooks; compile and analyze data for trends, yields, and process performance; contribute to run summaries and troubleshooting.

Compliance and quality:

• Follow SOPs and cGMP/cGLP principles as applicable; support investigations, maintain clean, safe work areas and proper documentation.

Cross-functional collaboration:

• Work closely with Manufacturing, Process Development, QC/Analytics, Supply Chain, and Facilities to ensure schedule adherence and issue resolution.

Continuous improvement: 

• Identify and implement improvements in sampling workflows, equipment readiness, and documentation practices.

Education and Experience:

• BS in Biochemistry, Bioengineering, Chemical Engineering, Molecular Biology, or related field with 4+yrs of relevant experience or MS with 2+ yrs experience in viral vector or biopharmaceutical production or process development.
• Experience with single-use bioreactors (client, Wave and 50L Stir Tank), TFF, depth filtration and affinity/ion exchange chromatography.
• Experience with analytical assays related to AAV.
• Direct experience with AAV production (upstream and downstream) at lab or pilot scale
• Experience in aseptic technique.
• Hands on experience with upstream bioreactors including Ambr250, Wave, and 50L stir tanks.

Knowledge, Skills & Abilities:

• Strong track record of building successful relationships with supervisors, peers, suppliers, customers, partners and stakeholders.
• Excellent communication skills and ability to work well with multiple individuals.
• Ability to work on several projects simultaneously and to switch focus as needed.
• Ability to keep accurate and organized records.
• Technical Competencies Familiarity with AAV production including transient transfection, suspension platforms and core downstream unit operations.
• Knowledge of in-process analytics relevant to AAV (e.g., titer by qPCR/dPCR/ddPCR, capsid protein assays, residual DNA, endotoxin, %Empty/Full assays).
• General molecular/microbiology skills.
• Track record of prioritizing multiple, complex, high priority tasks and ensuring timely delivery to meet project needs.
• A strong attention to detail.
• Working knowledge of Microsoft Office products, especially with Microsoft Excel.
• Effective communication, collaboration, and problem-solving skills in cross-functional settings.

The duties of this role are generally conducted in a lab environment:

• As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift 15 pounds unassisted.
• Work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de gown PPE.
• Use a computer.
• Engage in communications via phone, video, and electronic messaging.
• Engage in problem solving and non-linear thought, analysis, and dialogue.
• Collaborate with others.
• Maintain general availability during standard business hours.